FDA wants more data for Epigenomics' PMA

Epigenomics AG (Xetra:ECX) said it received a response letter from FDA for a PMA for its Epi proColon 2.0 blood-based colorectal cancer (CRC) screening test. The company said FDA requested additional data demonstrating the test would increase compliance for CRC screening in patients who do not undergo screening by recommended methods, such as colonoscopy or fecal immunochemical testing (FIT). The company expects it will need to conduct an additional trial to address the agency's requests because the original trials were performed in patients who had agreed to routine colonoscopy screening. Epigenomics has scheduled a meeting with FDA at the end of June to discuss next steps, including details around an additional trial. Epigenomics was down EUR 0.27 to EUR 6.12 on Monday. ...